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Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline (vCCC)

7. juli 2021 oppdatert av: Jeff Burns, MD, University of Kansas Medical Center

Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline: Phase I

This purpose of this study is to examine an aggressive method of blood pressure control that involves home blood pressure monitoring and management of medications by a team of clinical pharmacists in coordination with a primary care physician.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

33

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Kansas
      • Kansas City, Kansas, Forente stater, 66106
        • University of Kansas Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age 65 and older
  • Active patient in participating primary care clinic
  • Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity)
  • Elevated blood pressure as defined by:

Systolic Blood Pressure >140 at current visit AND documented history of hypertension OR Systolic Blood Pressure > 140 at current visit and at another visit in last 18 months OR Systolic Blood Pressure >160 at current visit

  • Sufficiently fluent in English to participate in study procedures
  • Adequate vision and hearing to complete study procedures

Exclusion Criteria:

  • Clinically significant illness that may affect safety or completion per their treating Primary Care Physician or study physician
  • End stage renal disease on dialysis
  • Chronic active disease with expected life expectancy < 2 years as determined by the study team

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Virtual Collaborative Care Clinic
The Virtual Collaborative Care Clinic arm participants use a home blood pressure monitor and routine blood pressure measurements will be uploaded to a dashboard monitored by clinical pharmacists. Blood pressure will be managed aggressively by the clinical pharmacists in coordination with Primary Care Physicians.
Annen: Virtual Collaborative Care Clinic
The vCCC will operate under a collaborative care agreement with the Primary Care Physicians as an extension (and not a replacement) of their care. Trained clinical pharmacists will monitor blood pressure and prescribe and adjust medications under the license of, and in communication with, the patient's Primary Care Physician. As part of the Primary Care Physician's team and per Primary Care Physician's directions, the pharmacists may coordinate blood pressure management with other clinicians such as cardiologists or nephrologists co-managing patients blood pressure.
Ingen inngripen: Control Intervention
The control intervention will consist of providing the participant with educational material and a home blood pressure monitor. The patients in the control group will not have support from Virtual Collaborative Care Clinic pharmacists. Routine blood pressure measures using their device will not be collected via the dashboard and will not be available for pharmacist review. Participants will continue to see their physicians for their usual care for blood pressure management.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility of system wide adoptability as assessed by survey responses
Tidsramme: Baseline
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on feasibility of implementation via a survey. The vCCC pharmacists and PCPs will be surveyed to assess feasibility and changing views of feasibility. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of feasibility.
Baseline
Feasibility of system wide adoptability as assessed by survey responses
Tidsramme: 3 Months Post Baseline
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on feasibility of implementation via a survey. The vCCC pharmacists and PCPs will be surveyed to assess feasibility and changing views of feasibility. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of feasibility.
3 Months Post Baseline
Feasibility of system wide adoptability as assessed by Physician Advisory Board meetings discussion
Tidsramme: Through study completion, an average of 9 months
Members of the Physician Advisory Board will be asked for feedback on system wide adoptability during the monthly Physician Advisory Board meetings. The meetings will be recorded and summarized.
Through study completion, an average of 9 months
Feasibility of system wide adoptability as assessed by vCCC Pharmacist Interviews
Tidsramme: Up to 2 months Post Baseline
Virtual Collaborative Care Clinic Pharmacists will be asked for feedback on feasibility of system wide adoption. We will conduct one-time semi-structured qualitative interviews with the Virtual Collaborative Care Clinic pharmacists. The Virtual Collaborative Care Clinic pharmacist will be interviewed to assess implementation factors including the auto-referral process and open-ended questions on the process and suggestions for improvement.
Up to 2 months Post Baseline
Replicability to other health systems as assessed by survey responses
Tidsramme: Baseline
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on replicability to other health systems via a survey. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of replicability to other health systems.
Baseline
Replicability to other health systems as assessed by survey responses
Tidsramme: 3 Months Post Baseline
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on replicability to other health systems via a survey. Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of replicability to other health systems.
3 Months Post Baseline
Replicability to other health systems as assessed by Physician Advisory Board meetings discussion
Tidsramme: Through study completion, an average of 9 months
Members of the Physician Advisory Board will be asked for feedback on replicability to other health systems during the monthly Physician Advisory Board meetings. The meetings will be recorded and summarized.
Through study completion, an average of 9 months
Replicability to other health systems as assessed by vCCC Pharmacist Interviews
Tidsramme: Up to 2 months Post Baseline
vCCC Pharmacists will be asked for feedback on replicability to other health systems. We will conduct one-time semi-structured qualitative interviews including open-ended questions.
Up to 2 months Post Baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Kansas Medical Center

Samarbeidspartnere

National Institute on Aging (NIA)

Etterforskere

  • Hovedetterforsker: Jeffrey Burns, MD, University of Kansas Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. oktober 2020

Primær fullføring (Faktiske)

2. juli 2021

Studiet fullført (Faktiske)

2. juli 2021

Datoer for studieregistrering

Først innsendt

30. september 2020

Først innsendt som oppfylte QC-kriteriene

9. oktober 2020

Først lagt ut (Faktiske)

14. oktober 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juli 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2021

Sist bekreftet

1. juli 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY146086
  • 1R61AG068483-01 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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